Devices, methods, and systems for the treatment and/or monitoring of damaged tissue
Inventors
Lawson, Daryl • Arena, Christopher Brian
Assignees
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Publication Number
US-11013910-B2
Publication Date
2021-05-25
Expiration Date
Abstract
Disclosed are methods, devices, and systems for treatment of an abnormal wound healing response. The methods, devices, and systems can be used to treat solid ulcerated tissue, such as diabetic foot ulcers (DFUs), arthritic tissue, muscle soreness, joint pain, varicose veins, obesity, and peripheral artery disease. Additionally, the methods, devices, and systems can promote the healing of xenograft, allograft, autograft, or engineered tissue following reconstruction surgery. The methods, devices, and systems include the ability to determine an optimal set of pulse parameters that are specific to wound healing. In embodiments, the methods, devices, and systems include components for guiding the user on electrode placement based on anatomical or electrical measurements, delivering a custom series of electric pulses, applying heat, and using feedback from physiologic measurements to control the device.
Core Innovation
The invention relates to therapeutic devices for an ulcer on a limb and for damaged tissue on a limb, where a covering includes a heating component and a heat source that generates heat to apply and transfer heat to the limb through the skin. The heating component is adapted to cover the ulcer area and beyond and to cover at least 40% of the limb to globally warm the limb and the ulcer, raising the temperature of the limb and not just providing local warming of the skin and the area of the ulcer.
In the disclosed therapeutic device, the covering is also adapted to off load pressure on the area of the ulcer, and to avoid applying pressure or shear on the ulcer. The device further includes a plurality of electrodes spaced from the area of ulcer and an electrical pulse generator configured to deliver electrical pulse stimulation to the patient through at least one electrode. The electrical pulse generator applies a biphasic wave form in a range of 0.25 mA to 100 mA with a pulse width in a range of 50 to 500 microseconds.
The device also includes a control unit configured to control the pulse generator and the heating component so that heat and electrical impulses are applied at the same time to the limb, while the device can monitor sensor inputs. In the foot-boot version, the control unit includes first and second sensors configured to detect, read and/or measure bioimpedance and a physiological characteristic selected from moisture, blood flow, and pH, and the control unit monitors bioimpedance and wound healing based on inputs from the sensors.
The disclosed approach further includes, in relevant embodiments, monitoring wound healing based on sensor input and applying the heat and electrical impulses at the same time under control. Remote monitoring is described in relation to transmitting a signal representing the state of the first or second sensor to a remote device.
Claims Coverage
Independent claims are directed to therapeutic devices that combine globally warming via a limb-covering heating component that covers at least 40% and extends beyond the lesion area, pressure off-loading, and simultaneous electrical pulse stimulation via spaced electrodes under control of a control unit. The claim set also includes sensor-monitored control features for bioimpedance and wound-healing indicators (moisture, blood flow, pH) in the foot version.
Global warming covering of at least 40% of the limb
A limb covering includes a heating component adapted to cover the ulcer and beyond the area of the ulcer and to cover at least 40% of the limb, including a heat source that generates heat to apply and transfer heat to the limb through the skin and to the ulcer and beyond the ulcer to globally warm the limb and the ulcer and raise the temperature of the limb.
Pressure off-loading while avoiding ulcer pressure or shear
The covering is adapted to off load pressure on the area of the ulcer such that the covering does not apply pressure or shear on the ulcer.
Spaced electrodes delivering biphasic electrical pulse stimulation
A plurality of electrodes is adapted to apply to the limb spaced from the area of ulcer, and an electrical pulse generator generates electrical impulses at least one electrode to deliver electrical pulse stimulation, wherein the electrical pulse generator applies a biphasic wave form in a range of 0.25 mA to 100 mA with a pulse width in a range of 50 to 500 microseconds.
Simultaneous control of heat and electrical impulses
A control unit in communication with a sensor and configured to control the pulse generator and the heating component to apply heat and electrical impulses at the same time to the limb.
Boot covering with global warming of the leg and ulcer area
A foot covering configured as a boot includes a heating component adapted to cover the area and beyond the area and to cover at least 40% of the leg, including a heat source that generates heat to apply and transfer the heat through the skin to globally warm the leg and the area of the ulcer to raise the temperature of the leg and not just provide local warming of the skin and the ulcer.
Bioimpedance and physiological characteristic sensing for monitoring
A first sensor detects, reads and/or measures bioimpedance, and a second sensor detects, reads and/or measures a physiological characteristic selected from moisture, blood flow, and pH.
Monitoring wound healing based on sensor inputs while powering heat and pulses
A control unit is in communication with the first and second sensors and is configured to power the pulse generator and the heating component and to apply heat and electrical impulses to the leg at the same time, and the control unit monitors the bioimpedance based on input from the first sensor and monitoring wound healing based input from the second sensor.
Pressure avoidance by adjusting covering to avoid constricting the limb
A covering includes a heating component configured to globally warm the limb and the area of the damaged tissue while covering at least 40% of the limb, and the covering is adapted to off load pressure on the area to avoid constricting the limb, with the control unit configured to adjust the covering to off load pressure.
Across the independent claims, the core inventive structure is a therapeutic device that globally warms at least 40% of the limb, including beyond the ulcer or damaged-tissue area, while off-loading pressure, and that simultaneously delivers biphasic electrical pulse stimulation via electrodes under control of a control unit. The foot-boot independent claim further adds sensor-based monitoring using bioimpedance and physiological characteristics selected from moisture, blood flow, and pH, and relates sensor-state monitoring to wound healing.
Stated Advantages
Globally warm the limb and the ulcer/damaged tissue by raising the temperature of the limb rather than just providing local warming of the skin and the area of ulcer/damaged tissue.
Off load pressure on the area of the ulcer while not applying pressure or shear on the ulcer.
Avoid constricting the limb by off-loading pressure on the area.
Simultaneously apply heat and electrical impulses to the limb under control.
Monitor bioimpedance and wound healing based on sensor inputs (moisture, blood flow, and/or pH).
Transmit a signal representing the state of the first or second sensor to a remote device.
Documented Applications
Therapeutic device for an ulcer on a limb of a patient, including a limb covering with a heating component and electrical pulse stimulation controlled at the same time.
Therapeutic device for an ulcer on a foot of a leg of a patient using a boot-like covering with a heating component and electrical pulse stimulation together with sensing of bioimpedance and physiological characteristics (moisture, blood flow, pH).
Therapeutic device for damaged tissue on a limb of a patient combining a warming covering and electrical pulse stimulation with pressure off-loading.
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